Nctid:
NCT06222424
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D004630", "term"=>"Emergencies"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M7796", "name"=>"Emergencies", "asFound"=>"Emergency", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>350}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2026-12-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-14", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-18", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of prescriptions and medication types sent to outpatient pharmacies", "timeFrame"=>"2 years", "description"=>"Number of prescriptions and medication types sent to outpatient pharmacies by EMPs pursuant to outpatient prescription issue resolution."}], "secondaryOutcomes"=>[{"measure"=>"Number of patients returning with complaint or diagnosis related to EMP generated prescriptions", "timeFrame"=>"2 years", "description"=>"Proportion of patients returning with a complaint or diagnosis related to index EMP-generated prescriptions at three and six-month time points"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Outpatient Prescription Issues"]}, "descriptionModule"=>{"briefSummary"=>"The study aims to document the utility of Methodist Charlton Medical Center (MCMC's)Emergency Medicine Pharmacist (EMP) Collaborative Practice Agreement (CPA )utilization for the resolution of outpatient prescription issues. Evaluation of utility will involve describing all EMP-written prescriptions pursuant to resolution of prescription issues realized after discharge.", "detailedDescription"=>"Use of an EMP CPA, which allows for broad prescriptive authority, will assist Emergency Department (ED )workflow by preventing a significant volume of new prescriptions needing to be sent by physician and mid-level providers. Will improve rates of ED re-visits. In addition, this Collaborative Practice Agreement (CPA) will not be associated with a large volume of new prescription errors."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients at MCMC who had a prescription sent by an EMP between November 1, 2021 and June 30, 2023 and a progress note and documenting the reason for the call and action taken by the EMP.\n\nExclusion Criteria:\n\n* CPA actions were misclassified as discharge prescription issue resolutions.\n* Patients with prescriptions pursuant to late culture review, formulation changes not requiring a new prescription, prescription transfers to another pharmacy, or simple retransmission of prescriptions.\n* Patients documented to have left the ED against medical advice."}, "identificationModule"=>{"nctId"=>"NCT06222424", "briefTitle"=>"Emergency Medicine Pharmacist Prescriptive Authority for Resolution of Outpatient Prescription Issues", "organization"=>{"class"=>"OTHER", "fullName"=>"Methodist Health System"}, "officialTitle"=>"Emergency Medicine Pharmacist Prescriptive Authority for Resolution of Outpatient Prescription Issues: a Descriptive Study", "orgStudyIdInfo"=>{"id"=>"045.PHA.2023.C"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"Patients at MCMC who had a prescription sent by an EMP between November 1, 2021 and June 30, 2023", "description"=>"Evaluation of utility will involve describing all EMP-written prescriptions pursuant to resolution of prescription issues realized after discharge.", "interventionNames"=>["Other: outpatient prescription issues"]}], "interventions"=>[{"name"=>"outpatient prescription issues", "type"=>"OTHER", "description"=>"Evaluation of utility will involve describing all Emergency Medicine Pharmacist (EMP)-written prescriptions pursuant to resolution of prescription issues realized after discharge", "armGroupLabels"=>["Patients at MCMC who had a prescription sent by an EMP between November 1, 2021 and June 30, 2023"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75203", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Jeff Wilson", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-1279", "phoneExt"=>"74681"}, {"name"=>"Colette N Ndjom", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-1289", "phoneExt"=>"71289"}], "facility"=>"Clinical Research Institute at Methodist Health System", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "centralContacts"=>[{"name"=>"Jeff Wilson", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-1279", "phoneExt"=>"74681"}, {"name"=>"Colette N Ndjom", "role"=>"CONTACT", "email"=>"mhsirb@mhd.com", "phone"=>"214-947-1289", "phoneExt"=>"71289"}], "overallOfficials"=>[{"name"=>"Kevin Burnham, Pharm.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Methodist Health System"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Methodist Health System", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
